A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

May 7, 2014 updated by: Takeda

A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

Study Overview

Detailed Description

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Study Type

Interventional

Enrollment (Actual)

397

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aichi
      • Nagoya-shi, Aichi, Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
      • Funabashi-shi, Chiba, Japan
      • Ichihara-shi, Chiba, Japan
      • Yachiyo-shi, Chiba, Japan
    • Ehime
      • Nihama-shi, Ehime, Japan
    • Fukui
      • Fukui-shi, Fukui, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Iizuka-shi, Fukuoka, Japan
      • Kitakyushu-shi, Fukuoka, Japan
      • Onga-gun, Fukuoka, Japan
      • Yanagawa-shi, Fukuoka, Japan
    • Fukushima
      • Koriyama-shi, Fukushima, Japan
    • Gifu
      • Takayama-shi, Gifu, Japan
    • Gunma
      • Takasaki-shi, Gunma, Japan
    • Hirosima
      • Hirosima-shi, Hirosima, Japan
    • Hokkaido
      • Ebetsu-shi, Hokkaido, Japan
      • Ishikari-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan
      • Kako-gun, Hyogo, Japan
      • Kawanishi-shi, Hyogo, Japan
      • Kobe-shi, Hyogo, Japan
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan
    • Kagawa
      • Marugame-shi, Kagawa, Japan
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan
    • Kanagawa
      • Hiratsuka-shi, Kanagawa, Japan
      • Kamakura-shi, Kanagawa, Japan
      • Kawasaki-shi, Kanagawa, Japan
      • Yamato-shi, Kanagawa, Japan
      • Yokohama-shi, Kanagawa, Japan
    • Kochi
      • Nankoku-shi, Kochi, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
    • Miyagi
      • Sendai-shi, Miyagi, Japan
    • Nagano
      • Matsumoto-shi, Nagano, Japan
      • Nagano-shi, Nagano, Japan
      • Suzaka-shi, Nagano, Japan
    • Nara
      • Nara-shi, Nara, Japan
    • Oita
      • Oita-shi, Oita, Japan
    • Okayama
      • Kurashiki-shi, Okayama, Japan
      • Okayama-shi, Okayama, Japan
    • Osaka
      • Hirakata-shi, Osaka, Japan
      • Ibaraki-shi, Osaka, Japan
      • Ikeda-shi, Osaka, Japan
      • Osaka-shi, Osaka, Japan
      • Sakai-shi, Osaka, Japan
      • Suita-shi, Osaka, Japan
      • Tondabayashi-shi, Osaka, Japan
      • Toyonaka-shi, Osaka, Japan
    • Saitama
      • Iruma-shi, Saitama, Japan
    • Shiga
      • Kusatsu-shi, Shiga, Japan
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan
      • Numazu-shi, Shizuoka, Japan
      • Yaizu-shi, Shizuoka, Japan
    • Tokushima
      • Komatsushima-shi, Tokushima, Japan
      • Naruto-shi, Tokushima, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Chiyoda-ku, Tokyo, Japan
      • Chuo-ku, Tokyo, Japan
      • Itabashi-ku, Tokyo, Japan
      • Machida-shi, Tokyo, Japan
      • Minato-ku, Tokyo, Japan
      • Ohta-ku, Tokyo, Japan
      • Setagaya-ku, Tokyo, Japan
      • Shinagawa-ku, Tokyo, Japan
      • Suginami-ku, Tokyo, Japan
    • Toyama
      • Toyama-shi, Toyama, Japan
    • Yamaguchi
      • Yamaguchi-shi, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. Participants who have completed TAK-385/CCT-101 study

Exclusion Criteria:

  1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
  2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
  3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
  4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
EXPERIMENTAL: TAK-385 10 mg QD
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
EXPERIMENTAL: TAK-385 20 mg QD
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
EXPERIMENTAL: TAK-385 40 mg QD
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
OTHER: Leuplin
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks
Other Names:
  • Leuplin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
Time Frame: Up to Week 24.
Measured by Dual-energy X-ray absorptiometry (DXA)
Up to Week 24.
Treatment-emergent Adverse Events
Time Frame: Up to Week 16
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Up to Week 16
Vital Signs
Time Frame: Up to Week 24
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
Up to Week 24
Body Weight
Time Frame: Up to Week 24
Up to Week 24
Electrocardiograms
Time Frame: Up to Week 24.
Up to Week 24.
Laboratory Values
Time Frame: Up to Week 24
Up to Week 24
Serum NTx
Time Frame: Up to Week 24
NTx is one of the biochemical bone metabolism markers
Up to Week 24
Serum BAP
Time Frame: Up to Week 24
BAP is one of the biochemical bone metabolism markers
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Score for Pelvic Pain
Time Frame: Up to Week 24
Pelvic pain will be assessed using the VAS as pain evaluation scale
Up to Week 24
VAS Score for Dyspareunia
Time Frame: Up to Week 24
Dyspareunia will be assessed using the VAS as pain evaluation scale
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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